This study will collect information on health status and risk behaviors, as well as basic demographic and biomedical information for a group of HIV positive adolescents receiving care at the ATN sites.

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Rates of adherence to medical regimens, sexual risk behavior, substance use and mental health concerns; basic demographic and biomedical data for adolescents and young adults with HIV infection engaged in care at the AMTUs. [ Time Frame: within 2 weeks of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To better understand the complex relationships between adherence to medical regimens, sexual risk behavior, substance use and mental health concerns, and basic demographic and biomedical data in adolescents and young adults with HIV infection. [ Time Frame: 1.3 years ] [ Designated as safety issue: No ]

All HIV-infected adolescents and young adults engaged in care at the 15 sites and their affiliates who are between 12 and 24 years of age, inclusive, are aware of their HIV status and understand written and/or verbal English will be eligible for inclusion in the study. In addition, new patients who have their initial clinic visit within the enrollment period will also be eligible for participation.

Other: Observation

Participants will have biomedical information extracted from their medical chart, will complete the ACASI questionnaire and have a face-to-face post-ACASI debriefing interview administered. Participants who do not have a documented HIV-1 viral load and/or CD4+ T-cells count from within the previous six months will also have venipuncture performed to obtain a blood sample for these tests to be performed.

Detailed Description:

The proposed study is a cross sectional study intended to be conducted at each of the 15 Adolescent Medicine Trials Units (AMTUs) participating in the ATN and to enroll all participating patients followed at each site. This approach will allow for the examination of the broad spectrum of youth participating in the ATN, including those newly entered into care.

Psychosocial and risk-taking behavioral data will be collected using Audio Compute-Assisted Self-Interview (ACASI); biomedical information will be collected through medical chart abstraction.

Eligibility

Ages Eligible for Study:

12 Years to 24 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

All HIV-infected adolescents and young adults engaged in care at the 15 sites and their affiliates who are between 12 and 24 years of age, inclusive, are aware of their HIV status and understand written and/or verbal English will be included in the master list from which the study sample will be derived.

Criteria

Inclusion Criteria:

Laboratory evidence of HIV-1 infection documented by a positive result on any of the following licensed tests at any time: Any HIV-1 antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA PCR, or plasma HIV-1 RNA PCR > 1,000 copies/ml;

Knowledge of HIV positive diagnoses;

Age 12 years through 24 years, inclusive;

Engaged in care at the AMTU or its affiliate and/or partnering clinic. Individuals will be considered to be engaged in care if:

Diagnosed less than or equal to 12 months prior to the date of approval to generate the master list and has attended a minimum of one visit since diagnosis for the management of HIV disease or its sequelae; or

Diagnosed more than 12 months prior to the date of approval to generate the master list and has had a minimum of one visit, as described above, within the past 12 months.

Intoxicated or under the influence of alcohol or other substances at the time of consent/assent.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009827